Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways (GAP)

The purpose of this study is to enrol generally healthy adults, who are asked to provide a blood sample, to study how the immune system works.

Study Overview

• Status: Completed
• Conditions: Immune System Diseases

Detailed Description

The primary purpose of this research is to develop a better understanding of how the immune system works. By studying immune function in many people, we will be able to determine the range of normal variation.

The second purpose is to enroll people who are willing to serve as comparisons in future research studies into the Genotype and Phenotype Research Registry (GAP Registry).

Volunteers are asked to provide information on age, ethnicity and medical history. Volunteers are asked to provide a blood sample of up to 100cc and allow us to contact you about additional studies.

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Controls

Description

Inclusion Criteria:

• Over age 18
• Generally healthy

Exclusion Criteria:

• History of autoimmune disease
• History of chronic immunodeficiency or chronic viral infections such as Epstein Barr virus, hepatitis or HIV
• Currently undergoing treatment for cancer
• Current treatment with immuno-suppressant drugs
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of healthy participants enrolled	This is a registry to enroll healthy individuals who are interested in being contacted about research studies they can participate in as a healthy control	5 years

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Alabama at Birmingham
• Investigators: Principal Investigator: Peter Gregersen, MD, The Feinstein Institute for Medical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 13, 2010

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: 09-081A; 1RC2AR059092-01 (U.S. NIH Grant/Contract)